FDA Grants Diazyme 510(k) Clearance to Market Its Direct HbA1c (Enzymatic, On-Board Lysis) Assay for Clinical Chemistry Analyzers
SAN DIEGO, CA--(Marketwired - November 30, 2016) - Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market its Direct HbA1c assay (Enzymatic, On-Board Lysis). HbA1c refers to glycated …